Dawn Bardot, PhD | Senior Program Manager, MDIC
With more than 15 years’ experience in computational model validation and uncertainty quantification, Dawn Bardot, PhD, brings a wealth experience to her role as Senior Program Manager, Modeling and Simulation at MDIC. She is passionate about the application of modeling and simulation to improve health care and lower the cost of bringing products to market.
Over the course of her career, Bardot has worked with startup companies, government organizations and academia on computer simulations and validation, including high intensity focused ultrasound, patient specific noninvasive FFR and medical oxygen regeneration for space flight. She has tackled the challenge of big data and data curation; disseminated and promoted the first computational model V&V standard; and recruited, hired and commandeered associated teams.
Most recently, she served as Director for Verification Validation & Test and Manager for Biomedical Testing with HeartFlow, Inc., in Redwood City, Calif., directing a team of software, mechanical, biomedical engineers, physicians and scientists to test and evaluate a software medical device utilizing high-performance computing as a web-based service for non-invasive evaluation of blood flow in coronary arteries.
Previous professional endeavors include: Assistant Professor in Mechanical & Aerospace Engineering at the University of Alabama/Huntsville; Senior Medical Devices Senior Innovation Fellow at the University of Minnesota/Minneapolis; Bio-Research Engineer with both Acoustx Corp. and Therus Corp.; and Mechanical Engineering Analyst with the Boeing Co.
Bardot holds a number of patents and pending applications, has been published in countless industry and educational journals, and is called upon to regularly address conferences and seminars. She is an active member of the American Society of Mechanical Engineers (ASME); serves as Vice Chair of the Verification and Validation in Computation Fluid Dynamics and Heat Transfer Committee; and is Sub-Group Chair of the Committee on Verification and Validation in Computational Methods for Medical Devices. In addition, she is a member of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE).
Dr. Bardot earned her PhD in Mechanical Engineering from the University of Washington, and served as an Innovation Fellow at the University of Minnesota Medical Devices Center. She also spent two summers as a Faculty Fellow at NASA Marshal Space Flight Center in Huntsville, Ala. In addition, she achieved an MS and BS in Mechanical Engineering from Kansas State University.
Robert Becker, MD, PhD | Chief Medical Officer, Office of In Vitro Diagnostics and Radiological Health, CDRH FDA
Robert Becker is Chief Medical Officer for the Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA, with special attention to inter-office coordination on regulation of newly emerging genetic/genomic IVD’s. Dr. Becker previously served as Director, Division of Hematology and Immunology Devices, in OIR (then named OIVD). He is experienced in regulation of IVD’s aimed at cell- and tissue-based specimens (e.g. classical hematology, flow cytometry, cytology, histopathology), plus blood coagulation tests, and immunoserologic tests.
Dr. Becker earned his MD and PhD in Immunology at Duke University, and he is board certified in anatomic and clinical pathology. He served in the United States Air Force as a pathologist at the Armed Forces Institute of Pathology, Washington, DC from 1983 to 2004, specializing in urologic pathology and with research and clinical service applying image analysis and flow cytometry to diagnostic pathology.
Karim Benali, MD | Vice President and Chief Medical Officer, Abiomed
Dr. Karim Benali joined Abiomed in 2004 as Vice President of Product Development responsible for planning and directing the full range of Abiomed’s product development policies, objectives and initiatives. In 2006, Dr. Benali was appointed as Abiomed’s Chief Medical Officer. Dr. Benali is responsible of leading the clinical strategy and initiatives to advance the field of acute heart failure for patients that are supported with Abiomed’s products through evidence based medicine, the design and execution of large and complex trials and registries. Dr Benali came to Abiomed with twelve years of international experience in medicine, clinical research, bioengineering and biostatistics, with a strong focus on cardiology.
Prior to Abiomed, Dr. Benali worked for GE HealthCare, where he led the introduction of two of the company’s top products in cardiology. As the Global Clinical Research Leader for the GE cardiovascular business, he led the clinical introduction of the world’s first digital flat panel imaging system that has become a standard in the CathLab. After that, as Global Manager, he pioneered the first cardiac procedures on the newly introduced hybrid imaging platform and positioned GE as market leader in Cardiac PET/CT. Prior to GE, Dr. Benali worked in the academic field at several renowned European medical and research institutions including the Assistance Publique – Hopitaux de Paris, the Cyceron research center and the Inserm Institute. He was part of the French multidisciplinary team that contributed actively to the bourgeoning field of the human brain mapping project using multimodality imaging techniques. In the 90s, he was a key member of the small team that pioneered one of the first real-time neuronavigation procedures in brain surgery using real-time quantitative spatial fusion of 3D MR/CT/PET images with patient’s brain. In parallel, Dr. Benali directed the clinical research program at the High Institute of Technology and Management in Paris, France where he taught biostatistics and Six Sigma methodology.
Dr. Benali earned an MD degree from Institut National de l’Enseignement Superieur des Sciences Medicales in Algiers, an MS in Bio-imaging and Bio-engineering from the University of Val de Marne — Paris XII, and a Pierre & Marie-Curie University Diploma in Biostatistics and Clinical Research from University Paris VI.
Steve Binion, PhD | Director Corporate Regulatory Affairs, BD
Steve has spent over 25 years in industry, with 20+ years of experience leading regulatory teams in support of biologics, therapeutic and diagnostic devices, drugs, and combination products. His formal regulatory experience began in 1992, as Director, Worldwide Regulatory for Allergan’s Botox biologic. In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs, and for the next 10 years led a global regulatory team with responsibility for 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical device products in the EU, including Class III devices incorporating medicinal products. In 2005 he joined BD as Director of Regulatory Affairs for BD Technologies, BD’s corporate research center in Research Triangle Park, NC. His responsibilities include providing support for early stage technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. He is active in a number of medical device and IVD policy issues on behalf of BD, through his involvement in several industry coalitions and Advamed. Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, St. Paul, Minnesota.
Robert Califf, MD | Deputy Commissioner Medical Products & Tobacco, FDA
Robert M. Califf, MD, MACC, was named Deputy Commissioner for Medical Products and Tobacco for the Food and Drug Administration (FDA) in February of 2015. Dr. Califf provides executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversees the Office of Special Medical Programs and provides direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.
Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.
While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center.
Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.
Stephanie Christopher | Program Manager, MDIC
Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie worked for seven years with an academic public health team working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012-13, Stephanie went on leave from her academic position to do a special assignment for the Food and Drug Administration Center for Devices and Radiological Health (CDRH), updating and training staff on a new risk communication process. Stephanie also teaches introductory communication courses in the College of Professional Studies at Marquette University.
Stephanie earned her Bachelor of Arts in Communication-Print Journalism from Pacific Lutheran University in Tacoma, Wash. and Master of Arts in Science, Health, and Environmental Communication from Marquette University in Milwaukee, Wis. Stephanie is also a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals.
Owen Faris, PhD | Clinical Trials Director (Acting), CDRH FDA
Dr. Owen Faris is the acting Clinical Trials Director for the Center for Devices and Radiological Health at the FDA, and has been in that position since its creation in February of 2014. Dr. Faris received his B.S. in Mechanical Engineering from Rice University in 1997, and his Ph.D. in Biomedical Engineering from Johns Hopkins University in 2003. Dr. Faris joined the FDA in 2003 as a reviewer in the Pacing, Defibrillator and Leads Branch in the Division of Cardiovascular Devices (DCD) and became a Deputy Director for the Division of Cardiovascular Devices in 2011. Dr. Faris has been very involved in the development of clinical trial policy for several years including developing policy regarding FDA’s decisions and communications for device clinical trials.
Suzanne Fiorino | Program Manager (Executive on Loan from Johnson & Johnson), MDIC
Suzanne Fiorino is Senior Director, MD&D Sustainability and Quality Strategy. Her responsibilities have included development and deployment of the sector’s Sustainability Strategy and leadership of the Quality and Regulatory Compliance Strategic Planning process for Johnson & Johnson’s Medical Devices & Diagnostics business and currently serves as the Program Manager for MDIC’s Case for Quality project.
Suzanne has previously held several leadership roles in both the Medical Devices & Diagnostics and Pharmaceuticals businesses at Johnson & Johnson in the areas of Health Care Compliance (HCC), International Regulatory, Quality, and Process Excellence.
Prior to joining Johnson & Johnson, Ms. Fiorino was the owner of Amgis, Ltd., a Quality Improvement and Compliance consulting firm, and she also held positions at QualPro Inc. and Union Carbide Corporation.
Ms. Fiorino holds an MBA in New Ventures Management from the University of Tennessee at Knoxville, a B.S. in Chemistry from Canisius College, and has completed her coursework toward a doctorate in Industrial/Organizational Psychology. She is a Six Sigma Master Black Belt and a Senior Member of ASQ.
Bill Hawkins | Retired Chairman & CEO Medtronic, Lead Director, Immucor and Chairman, MDIC
Bill Hawkins is a Senior Advisor for TPG Capital and Lead Director of Immucor, Inc., a private company, wholly owned by TPG. Immucor is a market leader in helping secure the world’s blood supply through automation.
Prior to joining Immucor in 2011, Mr. Hawkins served as Chairman and CEO of Medtronic, one of the worlds’ largest and most innovative medical technology companies. Mr. Hawkins assumed the role of CEO in 2007 and became Chairman of the Board in 2008. He joined Medtronic in 2002.
Mr. Hawkins joined Medtronic from Novoste Corp., where he had been President and Chief Executive Officer since 1998. He previously held senior leadership positions at American Home Products, Johnson & Johnson, Guidant Corp., and Eli Lilly & Co. He began his medical technology career with Carolina Medical Electronics in 1977.
Mr. Hawkins received his bachelor’s degree in electrical and biomedical engineering from Duke University in 1976, where he also conducted medical research in pathology. He then went on to earn an MBA from the Darden School of Business, University of Virginia in 1982. Mr. Hawkins became a member of the Duke University Board of Trustees in 2011 and serves on the Business and Finance and the Academic Affairs Committees. In 2012, he was appointed as a member of the Duke University Health System, Inc. and serves on the Audit and Compliance Committee.
Mr. Hawkins is the Chairman of MDIC and was recently elected as the 2013 President of the American Institute of Medical and Biological Engineering (AMIBE). He serves as a Director on the Board of AdvaMedDX, is the Chairman of the Board for KeraNetics, and on the Board of Thoratec Corporation, a NYSE-listed medical device company.
Mr. Hawkins also serves as a Member of the Advisory Boards at nContact Surgical, Arboretum Ventures, Radius Ventures, LLC, Accuitive Medical Ventures, and the A*STAR SERC Cluster Advisory Board in Singapore.
Mr. Hawkins and his wife, Sharon Hawkins, have three children: Elizabeth, Duke University Class of 2009; Julia, Duke University Class of 2012; and Will, Duke University Class of 2014.
Carolyn Hiller | Program Manager (Acting), MDIC
Carolyn Hiller joined MDIC in July 2015 as Acting Program Manager for their nascent Clinical Diagnostics initiative. She brings diverse experiences in the health sector; in addition to nearly a decade working in the medical device industry, she brings executive leadership experience with national organizations representing patients, researchers, physicians, and clinical facilities. She guided the organizations she worked with to create successful alliances with both the National Institutes of Health and the American Medical Association. She has an MBA from the University of St. Thomas, St. Paul, Minnesota, as well as a BA in Marketing from Metropolitan State University, and an AAS in Animal Health Technology from the University of Minnesota.
Telba Irony, PhD | Acting Head, Quantitative Innovation Program, CDRH FDA
Telba Irony is currently leading the Quantitative Innovation program at the Center for Devices and Radiological Health at the FDA. She received her Ph.D. from the University of California at Berkeley and joined CDRH to help implement the use of Bayesian methods in medical device clinical trials.
Telba is a fellow of the American Statistical Association and an elected member of the International Statistical Institute.
She was instrumental in preparing the CDRH guidance documents for the Use of Bayesian Statistics in medical device clinical trials, on Factors to Consider when Making Benefit – Risk Determinations for medical devices and on the Submission of Patient Preference Information for evaluation of medical devices.
In 2014 she received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm.
Ross Jaffe, MD | Director, National Venture Capital Association and Managing Director, Versant Ventures
Ross Jaffe is a venture capitalist who focuses on early-stage investing in medical technology. Ross is a Managing Director of Versant Ventures, a firm he co-founded in 1999 after spending nine years at Brentwood Venture Capital where, as a general partner, he led investments in medical devices, drug delivery, and healthcare information systems companies.
During his twenty five years in venture capital, Ross has served on the boards of a number of successful life science companies, including Acclarent, St Francis Medical Technologies, Ablation Frontiers, Insulet, Therasense, and Novacept. He currently serves on the boards of Alter-G, Cerephex, Intersection Medical, Minerva Surgical, and Sympara.
Active in the health care venture capital community, Ross serves as a Director of the National Venture Capital Association (NVCA) and as a Director of the Medical Device Innovation Consortium (MDIC), where he is the Board Champion for the Patient Centered Benefit-Risk Project. He chairs the Board of Overseers of the Geisel School of Medicine at Dartmouth and is a member of the Board of Advisors of the Dartmouth Institute for Health Policy & Clinical Practice.
Ross is trained as an internal medicine physician, having attended medical school at Johns Hopkins and completing his residency training at the University of California, San Francisco, where he remained a part-time physician until 1995. He also holds an MBA from Stanford.
Bryan Luce, PhD | Chief Science Officer, PCORI
Dr. Bryan R. Luce is Chief Science Officer at the Patient-Centered Outcomes Research Institute. He is responsible for leading the development and implementation of PCORI’s patient-centered comparative clinical effectiveness research (CER) agenda. Luce previously founded the outcomes research firm MEDTAP® International, serving as its chairman, president, and chief executive officer and was the senior vice president for science policy at the United BioSource Corporation. Earlier, Luce was director of Battelle’s Centers for Public Health Research and Evaluation; director of the Office of Research and Demonstrations, Centers for Medicare and Medicaid Services; and a senior analyst at Office of Technology Assessment of the United States Congress.
Luce’s research has focused on improving methods and related policies for more efficient healthcare decision making. He has authored more than 100 scientific publications, including three textbooks on health technology assessment, health policy, and health economics. In 2008, Luce founded the Pragmatic Approaches to Comparative Effectiveness (PACE) Initiative, which studies novel methods to conduct analytical efficiency comparative effectiveness trials. Previously, he founded the Bayesian Initiative in Health Economics and Outcomes Research. He has been an advisor to numerous government and nonprofit agencies, as well as pharmaceutical and device firms worldwide; a member or chair of socioeconomic and public health policy advisory boards for leading biopharmaceutical companies; and a member of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC).
Luce is also a past president of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and in 2008 received the Society’s Avedis Donabedian Outcomes Research Lifetime Achievement Award. He has held adjunct faculty positions in the Department of Health Policy at Jefferson Medical College, the Leonard D. Schaeffer Center for Health Policy and Economics at the University of Southern California, and the Department of Pharmacy at the University of Washington. A former Special Forces Officer, Luce is a Lieutenant Colonel (Retired), US Army Reserves. He holds MS (public health) and MBA degrees from the University of Massachusetts at Amherst, and a PhD in health services research from the University of California at Los Angeles.
Aran Maree, MD| Chief Medical Officer, Medical Devices & Diagnostics, Johnson & Johnson
Dr. Aran Maree is Chief Medical Officer of the Medical Devices family of companies at Johnson & Johnson, based in New Jersey, USA. In his capacity as Chief Medical Officer, Aran leads the sector Medical Safety Organization and chairs the sector Development Committee, Medical Safety Council and Clinical Leadership Council. Aran has more than 20 years’ experience in the world of healthcare, pharmaceuticals and medical devices in Europe, the Middle East, Asia Pacific and the USA, including working at companies such as The Boston Consulting Group, Merck and Johnson & Johnson. Aran graduated with honors from the Royal College of Surgeons of Ireland and is a Member of the Royal College of Physicians in Ireland. He trained in internal medicine and interventional cardiology in Dublin, Ireland and Sydney, Australia.
Michelle McMurry-Heath MD, PhD | WW Vice President, Regulatory Affairs Medical Devices, Johnson & Johnson
is a physician and scientist with more than two decades of experience working to bring cutting-edge medical technologies to patients.
Prior to joining Johnson & Johnson, Michelle was responsible for providing advisory and advocacy services to clients across the health and life sciences sector at FaegreBD Consulting. As the lead for the firm’s regulatory team, she delivered insights on the current regulatory landscape for medical devices and pharmaceuticals, while also working to shape the future regulatory environment.
Previously, she served as Associate Center Director for Science at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the branch of the agency responsible for regulating medical devices. In her role at the FDA, Michelle led the creation of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the agency and almost 50 members of the medical technology industry and patient advocacy community. She also led efforts at the agency to stimulate innovation for pediatric and special patient populations, to develop standards, and to measure the impact of FDA-sponsored research.
Prior to the FDA, Michelle was founding director of the Health, Biomedical Science and Society Initiative at the Aspen Institute. She has been a MacArthur Fellow at the Council on Foreign Relations and a Robert Wood Johnson Foundation Health and Society Scholar focused on biomedical innovation. Michelle previously served as Senator Joseph Lieberman’s senior health policy legislative assistant from 2001-04 and served on President Obama’s transition team for the National Science Foundation.
Michelle holds a joint M.D./Ph.D. degree from Duke University School of Medicine and completed her undergraduate training at Harvard University in biochemistry.
Bill Murray | President & CEO, MDIC
Bill joined MDIC in August of 2013 as the first President and CEO. He has over 25 years of senior leadership experience spanning the range of privately financed start-up to billion dollar plus global businesses. Bill’s small company experience spans 5 years as CEO and executive consultant, including 3 years as CEO of ReShape Medical. His large company experience includes leadership as the Molecular Biology Division President of Applied Biosystems, and at Medtronic where he spent nearly 20 years in various senior leadership positions, including President of the Pacemaker Business. Bill has also served as interim President and CEO of MTS Systems (MTSC) a public $500M industrial technology company. Bill currently serves on the Boards of MDIC, ILT, Sonex Health and Meso-FLow and previously served on the Boards of MTS Systems, LifeSync Holdings, and ReShape Medical. Bill has also served on various industry association and community leadership boards. He earned a Bachelor of Science Degree in Electrical Engineering from The University of Florida.
Kyle Myers, PhD | Director, Division of Imaging, Diagnostics, and Software Reliability, Office of Science & Engineering Laboratories, CDRH FDA
Kyle J. Myers, Ph.D., received bachelor’s degrees in Mathematics and Physics from Occidental College in 1980 and a Ph.D. in Optical Sciences from the University of Arizona in 1985. Following a post-doc at the University of Arizona, she worked in the research labs of Corning Inc. Since 1987 she has worked for the Center for Devices and Radiological Health of the U.S. Food and Drug Administration, where she is currently the Director of the Division of Imaging, Diagnostics, and Software Reliability in CDRH’s Office of Science and Engineering Laboratories. In this capacity she serves as the director for CDRH research programs in x-ray imaging systems, image reconstruction and analysis methods, digital pathology systems, medical display devices, computer-aided diagnostics, and multivariate statistical assessment methodologies for imaging clinical trials. She holds adjunct faculty positions at the University of Arizona and Georgetown University. Dr. Myers is a Fellow of the OSA, SPIE, and AIMBE and a member of the National Academy of Engineering. Along with Harrison H. Barrett, she is the coauthor of Foundations of Image Science, published by John Wiley and Sons in 2004 and winner of the First Biennial J.W. Goodman Book Writing Award from OSA and SPIE. She is the FDA Principal Investigator on the MDIC Computer Modeling and Simulation Project. She is an associate editor for the Journal of Medical Imaging and Medical Physics.
Kathryn O’Callaghan | Associate Center Director for Science and Strategic Partnerships (Acting), CDRH FDA
Kathryn O’Callaghan is Acting Associate Center Director, Science and Strategic Partnerships, at FDA’s Center for Devices and Radiological Health. Katie oversees the CDRH Patient Preference Initiative, the Network of Experts Program, the Medical Device Development Tools (MDDT) Qualification Program, and a variety of activities to advance Regulatory Science. She also manages CDRH participation in the Medical Device Innovation Consortium and the Clinical Trials Transformation Initiative. Her team includes the External Expertise and Partnership staff (led by Annie Saha), pediatrics, led by CDRH Chief Pediatric Medical Officer (Dr. Vasum Peiris), and cross-Center working groups dedicated to a variety of initiatives including improving diversity of clinical data and study participation, and developing and qualifying broadly applicable tools like PROs and computer models.
Katie’s prior work in her 10 years at FDA includes leading multi-disciplinary teams in policy and program analysis and development in a variety of cross-cutting areas, and premarket evaluation of complex cardiovascular devices including drug-eluting stents, prosthetic heart valves, and circulatory support systems for adult and pediatric uses.
Prior to joining FDA, Katie worked as an R&D engineer for a MedTech industry start-up, with responsibilities in development and testing of design improvement prototypes including animal studies, long term reliability testing, and analysis of devices after investigational human use. She also served as a research liaison between the University of Pittsburgh Medical Center and MIT Biotech Process Engineering Center on a collaborative project to develop a viable extracorporeal bioartificial liver support system. Kathryn studied Bioengineering at the University of Pittsburgh with a dual focus in Artificial Organs and Biosystems/Signals. She also has a BA in German Language & Literature.
Bryan Olin PhD, | Vice President, Clinical, Quality and Regulatory, Cyberonics
Bryan D. Olin, PhD, joined Cyberonics as Vice President, Quality in May 2009. In August 2009, Dr. Olin assumed interim responsibility for Clinical Affairs and was named Vice President, Clinical Affairs & Quality in November 2009. Subsequently, in April 2011, he assumed responsibility for Regulatory Affairs. He joined Cyberonics from Zeltiq Aesthetics, Inc., a privately held medical technology company in the San Francisco Bay Area, where he served as Sr. Director, Quality Assurance beginning in October 2007. Prior to Zeltiq Aesthetics, Dr. Olin was employed at the LifeScan and Cordis franchises of Johnson & Johnson from 1999 to 2007, holding several positions of increasing responsibility in quality assurance, statistics and clinical data management. Dr. Olin began his career with Procter & Gamble in 1993 after obtaining his PhD in Statistics from Iowa State University.
Annie Saha | Director of External Expertise and Partnerships (EEP), CDRH FDA
Anindita (Annie) Saha is the Director of External Expertise and Partnerships (EEP) in the FDA’s Center for Devices and Radiological Health (CDRH). EEP coordinates the Patient Preference Initiative, Network of Experts Program, public-private partnerships including the Medical Device Innovation Consortium (MDIC), the Critical Path and Regulatory Science Initiatives, the Medical Device Fellowship Program, and technology transfer and collaboration efforts for the Center. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to EEP to coordinate Critical Path and Regulatory Science activities for the Center. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.
Randy Schiestl | Vice President, Global Technology, Boston Scientific
Randall (Randy) Schiestl, PMP, is the Vice President of Global Technology at Boston Scientific, where he leads a team to deliver computational analysis, technology roadmapping, product design, packaging & labeling, knowledge management, and lab & test services. Randy’s latest role is building Global Technical Community across the corporation. He has BSME, MBA and Executive MBA degrees from the University of Minnesota. Randy received the UMAA Alumni Service Award from the College of Science & Engineering in 2011 and the Design of Medical Device Conference Award in 2012.
Jeff Shuren, MD, JD | Director, CDRH FDA
Jeffrey Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.
Jeff has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
From 1999 to 2000, Jeff served as a detailee on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, he also was a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section, where he supervised and designed clinical studies on human reasoning.
As director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services from 2001 to 2003, Jeff oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.
Jeff received his BS and MD degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his JD from the University of Michigan.
Jan Welch | Director, Office of Compliance (Acting), CDRH FDA
Jan is a proven public health champion with 30+ years’ experience in protecting and improving patient health in both public service and the private sector.
She is a seasoned regulatory expert with medical device and biologic product expertise. Jan currently leads the 200 member Office of Compliance at FDA’s Center for Devices and Radiological Health by promoting quality and fostering innovation of medical devices. In this position she oversees the assessment and enhancement of medical device quality through broad-based FDA change initiatives and daily operations.
Jan has over 20 years of experience in CDRH’s Office of Compliance. In her position as Deputy Office Director Jan managed the Office’s regulatory affairs policies, programs, and administrative and legal actions. This included direct oversight responsibility for all activities related to premarket and labeling compliance, manufacturing and quality, and international compliance operations.
Previously, Ms. Welch served as a Quality System Expert in CDRH for eleven years. During this time Ms. Welch provided expert opinion on medical device legal cases; developed and presented extensive internal and external training on the Quality System regulation; and represented FDA and the US in several international guidance and standards development activities, including the Global Harmonization Task Force and various ISO Technical Committees.
Prior to her position with CDRH, Jan worked for over four years in FDA’s Center for Biologics Evaluation and Review, Office of Compliance, Division of Case Management. Before joining FDA Jan worked for the American Red Cross in Washington, DC, the National Institutes of Health in Bethesda, MD, and Vanderbilt University Medical Center in Nashville, TN.
Jan graduated with a Master in Health Sciences in Immunohematology from the Medical University of South Carolina. She holds a B.A. in Biology from Wake Forest University, and completed a one-year certificate program in Medical Technology at Vanderbilt University. She is an ASCP registered Medical Technologist and Specialist in Blood Banking.